DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 20 July 2026 wherein Claims 59 – 67 and 72 – 82 are amended, Claims 1 – 58 and 68 – 71 are previously cancelled, and no claims have been newly added or cancelled. Therefore, Claims 59 – 67 and 72 – 82 are currently pending.
The Applicant’s amendment to the Claims dated 20 July 2026 has overcome each Claim Objection set forth in the Non-Final Rejection dated 20 April 2026 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Claim Objection set forth in the Non-Final Rejection are withdrawn.
The Applicant’s amendment to the Claims dated 20 July 2026 has overcome each Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection. Therefore, each Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 8 – 11, filed 20 July 2026, with respect to the rejection(s) of claim(s) 59 and its respective dependent claims under 35 U.S.C. §§ 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cowe (US 2013/0317447 A1) and Nita et al. (US 2005/0113688 A1).
Claim Interpretation
The claim language of “user-powered automatic injection assembly” is interpreted to be an automatic injection assembly that is initiated via the user actuating a control feature. After actuating the control feature, the assembly automatically injects the medicament into the subject. This interpretation is consistent with the third full paragraph of page 7 of the Specification dated 8 September 2023.
Claim Objections
Claims 63 and 64 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 75 and 77, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 62 is objected to because of the following informalities:
Claim 62 recites “when said sealing element seating assembly is in forward motion.” The Examiner suggests amending this to recite “when said sealing element seating assembly is in said forward motion” to provide antecedent basis for this structure within the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 59 – 61, 64, 72, 76, and 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe (US 2013/0317447 A1) and Nita et al. (US 2005/0113688 A1) (hereinafter referred to as “Nita”).
With regards to claim 59, Cowe discloses a medicament injector comprising:
a reusable, user-powered automatic injection assembly (see Figure 2 and [0011] where the reusable, user-user powered automatic injection assembly is everything besides the syringe 7) including a medicament injection subassembly (47, 49) (see [0041]); and
a medicament module (7) (see [0004]) removably insertable into said reusable, user-powered automatic injection assembly (see [0011]);
said medicament injection subassembly including a damping driver element (47), a sealing element (49) mounted on said damping driver element (see [0041] “An "O" ring 49 is located around the circumference of one end of the piston 47, and is held in place by a circumferentially extended groove 50 formed around the surface of the piston.”) and slidable relative to a stationary surface (see the surface along the proximal chamber 44 in Figures 4, 5, and 6) of said reusable, user-powered automatic injection assembly, and a sealing element seating assembly (50) (see [0041]) which provides for varying damping of forward motion of said medicament injection subassembly along a longitudinal axis (see [0046] – [0048]).
However, Cowe is silent with regards to the following:
the sealing element being a plurality of sealing elements.
Nonetheless Nita, which is within the analogous art of dampening structures (see [0039]), teaches that any number of absorber members such as o-rings depending on the level of vibration absorption or dampening desired (see [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the number of sealing elements of the medicament injection subassembly of the medicament injector of Cowe in view of a teaching of Nita such that the sealing element is a plurality of sealing elements mounted on the damping driver element. One of ordinary skill in the art would have been motivated to make this modification because Nita teaches that the number of sealing elements used for dampening can be adjusted to match a desired amount of dampening. See [0039] of Nita. Additionally, the number of grooves 50 of Cowe formed around the surface of the piston 47 is also modified to accommodate the number of sealing elements of the medicament injection subassembly.
The medicament injector of Cowe modified in view of a teaching of Nita will hereinafter be referred to as the medicament injector of Cowe and Nita.
With regards to claim 60, the medicament injector of Cowe and Nita teaches the claimed invention of claim 59, and the medicament injector of Cowe and Nita further teaches wherein said plurality of sealing elements and said sealing element seating assembly are configured to provide vacuum damping of said forward motion of said medicament injection subassembly along said longitudinal axis (the claim language of “wherein said plurality of sealing elements and said sealing element seating assembly are configured to provide vacuum damping of said forward motion of said medicament injection subassembly along said longitudinal axis” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. MPEP 2114. The Office submits that the device of Cowe and Nita meets the structural limitations of the claim and is capable of providing vacuum damping of said forward motion of said medicament injection subassembly along said longitudinal axis based on paragraphs [0041], [0042], and [0046] – [0048] of Cowe).
With regards to claim 61, the medicament injector of Cowe and Nita teaches the claimed invention of claim 59, and the medicament injector of Cowe further teaches wherein said reusable, user-powered automatic injection assembly (see Figure 2 and [0011] where the reusable, user-user powered automatic injection assembly is everything besides the syringe 7) also includes an end cover (44) (see [0040]) and said sealing element seating assembly (50)(see [0041]) with said plurality of sealing elements (49) (see the rejection of Claim 59 where the o-ring 49 and the groove 50 are duplicated in view of Nita) mounted thereon is operatively and frictionally engaged with said end cover (see [0042] and Figures 4 – 6).
With regards to claim 64, the medicament injector of Cowe and Nita teaches the claimed invention of claim 61, and the medicament injector of Cowe further teaches wherein a vacuum is created between said end cover (44) (see [0040]) and said plurality of sealing elements (49) (see the rejection of Claim 59 where the o-ring 49 and the groove 50 are duplicated in view of a teaching of Nita) during said forward motion (see [0041], [0042], [0045] – [0049], and Figures 4 – 6).
With regards to claim 72, the medicament injector of Cowe and Nita teaches the claimed invention of claim 60, and the medicament injector of Cowe further teaches wherein said reusable, user-powered automatic injection assembly (see Figure 2 and [0011] where the reusable, user-user powered automatic injection assembly is everything besides the syringe 7) also includes an end cover (44) (see [0040]) and said sealing element seating assembly (50)(see [0041]) with said plurality of sealing elements (49) (see the rejection of Claim 59 where the o-ring 49 and the groove 50 are duplicated in view of Nita) mounted thereon is operatively and frictionally engaged with said end cover (see [0042] and Figures 4 – 6).
With regards to claim 76, the medicament injector of Cowe and Nita teaches the claimed invention of claim 72, and the medicament injector of Cowe further teaches wherein the vacuum is created between said end cover (44) (see [0040]) and said plurality of sealing elements (49) (see the rejection of Claim 59 where the o-ring 49 and the groove 50 are duplicated in view of a teaching of Nita) during said forward motion (see [0041], [0042], [0045] – [0049], and Figures 4 – 6).
With regards to claim 77, the medicament injector of Cowe and Nita teaches the claimed invention of claim 61, and the medicament injector of Cowe further teaches wherein a vacuum is created between said end cover (44) (see [0040]) and said plurality of sealing elements (49) (see the rejection of Claim 59 where the o-ring 49 and the groove 50 are duplicated in view of a teaching of Nita) during said forward motion (see [0041], [0042], [0045] – [0049], and Figures 4 – 6).
Claim(s) 62, 65 – 67, 78, and 80 – 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe and Nita as applied to claims 59, 60, and 61 above, and further in view of Helmer et al. (US 2015/0302778 A1; hereinafter referred to as “Helmer”).
With regards to claim 62, the medicament injector of Cowe and Nita teaches the claimed invention of claim 61, however Cowe is silent with regards to wherein when said sealing element seating assembly is in rearward motion, said frictional engagement with said end cover is decreased and when said sealing element seating assembly is in forward motion, said frictional engagement with said end cover is increased.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches wherein when said sealing element seating assembly (12) (see [0041]) is in rearward motion (26) (see [0041] and Fig. 2), said frictional engagement with said end cover (36) (see [0042]) is decreased (see [0043] “At least it experiences a reduced radially outwardly directed pressure and therefore exerts correspondingly reduced dynamic friction towards the inside wall 36.”) and when said sealing element seating assembly is in forward motion (24) (see [0041] and Fig. 1), said frictional engagement with said end cover is increased (see [0042] “Consequently, when the piston 10 is displaced in distal direction 24, a comparatively large friction force between the ring 14 and the inside wall 36 of the body 32 is generated.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of Cowe and Nita in view of a teaching of Helmer such that when said sealing element seating assembly is in rearward motion, said frictional engagement with said end cover is decreased and when said sealing element seating assembly is in forward motion, said frictional engagement with said end cover is increased. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
The medicament injector of Cowe and Nita modified in view of Helmer will hereinafter be referred to as the medicament injector of Cowe, Nita, and Helmer.
With regards to claim 65, the medicament injector of Cowe and Nita teaches the claimed invention of claim 59, and the medicament injector of Cowe and Nita further teaches wherein said sealing element seating assembly (50) (see [0051] of Cowe) includes a plurality of seating areas (see the rejection of Claim 59 above where the number of grooves 50 formed around the surface of the piston 47 is also modified to accommodate the plurality of o-rings 49, see [0041] of Cowe and [0039] and [0040] of Nita) at a rearward end thereof (see Figures 4 – 6 of Cowe and the location of the o-ring 49 and groove 50 being on the rearward end of the piston 49 and at 50 in Figure 1A of Nita).
However, Cowe is silent with regards to said plurality of seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said plurality of seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Cowe and Nita in view of a teaching of Helmer such that said plurality of said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
The medicament injector of Cowe and Nita modified in view of Helmer will hereinafter be referred to as the medicament injector of Cowe, Nita, and Helmer.
With regards to claim 66, the medicament injector of Cowe, Nita, and Helmer teaches the claimed invention of claim 65, and the medicament injector of Cowe, Nita, and Helmer further teaches wherein said plurality of sealing elements are configured to engage said planar surfaces during a rearward motion of said medicament injection subassembly and are further configured to engage said tapered surfaces during said forward motion (the language of “wherein said plurality of sealing elements are configured to engage said planar surfaces during a rearward motion of said medicament injection subassembly and are further configured to engage said tapered surfaces during said forward motion” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. MPEP 2114. The Office submits that the medicament injector of Cowe, Nita, and Helmer meets the structural limitations of the claim wherein the said plurality of sealing elements is configured to engage said planar surfaces during said rearward motion and is further configured to engage said tapered surfaces during said forward motion based on paragraphs [0041] and [0042] and Figures 1 – 2 of Helmer).
With regards to claim 67, the medicament injector of Cowe, Nita, and Helmer teaches the claimed invention of claim 62, and the medicament injector of Cowe, Nita, and Helmer further teaches wherein said increased frictional engagement with said end cover (44) (see [0040] of Cowe) and a vacuum created (see [0041], [0042], and [0046] – [0048] of Cowe) between said end cover and said plurality of sealing elements (49) (see the rejection of claim 59 above where the o-ring 49 of Cowe is duplicated in view of the teaching of Nita) during said forward motion are configured for preventing damage to at least part of said medicament injector during said forward motion of said sealing element seating assembly (the language “wherein said increased frictional engagement with said end cover and a vacuum created between said end cover and said plurality of sealing elements during said forward motion are configured for preventing damage to at least part of said medicament injector during said forward motion of said sealing element seating assembly” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. MPEP 2114. The Office submits that the medicament injector of Cowe, Nita, and Helmer meets the structural limitations of the claim, and is capable of preventing damage to at least part of the medicament injector during forward motion of the sealing element seating assembly because the partial vacuum created by the O-ring and sealing element seating assembly during forward motion see [0041], [0042], and [0046] – [0048] of Cowe).
With regards to claim 78, the medicament injector of Cowe, Nita, and Helmer teaches the claimed invention of claim 62, and the medicament injector of Cowe further teaches wherein a vacuum is created between said end cover (44) (see [0040]) and said plurality of sealing elements (49) (see the rejection of Claim 59 where the o-ring 49 and the groove 50 are duplicated in view of a teaching of Nita) during said forward motion (see [0041], [0042], [0045] – [0049], and Figures 4 – 6).
With regards to claim 80, the medicament injector of Cowe and Nita teaches the claimed invention of claim 60, and the medicament injector of Cowe and Nita further teaches wherein said sealing element seating assembly (50) (see [0051] of Cowe) includes a plurality of seating areas (see the rejection of Claim 59 above where the number of grooves 50 formed around the surface of the piston 47 is also modified to accommodate the plurality of o-rings 49, see [0041] of Cowe) at a rearward end thereof (see Figures 4 – 6 of Cowe and the location of the o-ring 49 and groove 50 being on the rearward end of the piston 49).
However, Cowe is silent with regards to said plurality of seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said plurality of seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Cowe and Nita in view of a teaching of Helmer such that said plurality of said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
With regards to claim 81, the medicament injector of Cowe and Nita teaches the claimed invention of claim 61, and the medicament injector of Cowe and Nita further teaches wherein said sealing element seating assembly (50) (see [0051] of Cowe) includes a plurality of seating areas (see the rejection of Claim 59 above where the number of grooves 50 formed around the surface of the piston 47 is also modified to accommodate the plurality of o-rings 49, see [0041] of Cowe) at a rearward end thereof (see Figures 4 – 6 of Cowe and the location of the o-ring 49 and groove 50 being on the rearward end of the piston 49).
However, Cowe is silent with regards to said plurality of seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said plurality of seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Cowe and Nita in view of a teaching of Helmer such that said plurality of said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
With regards to claim 82, the medicament injector of Cowe, Nita, and Helmer teaches the claimed invention of claim 62, and the medicament injector of Cowe and Nita further teaches wherein said sealing element seating assembly (50) (see [0051] of Cowe) includes a plurality of seating areas (see the rejection of Claim 59 above where the number of grooves 50 formed around the surface of the piston 47 is also modified to accommodate the plurality of o-rings 49, see [0041] of Cowe) at a rearward end thereof (see Figures 4 – 6 of Cowe and the location of the o-ring 49 and groove 50 being on the rearward end of the piston 49).
However, Cowe is silent with regards to said plurality of seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said plurality of seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Cowe, Nita, and Helmer in view of a teaching of Helmer such that said plurality of said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
Claim(s) 63, 75, and 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe, Nita, and Helmer as applied to claim 62 above, and further in view of Shill (US 3,724,973 A).
With regards to claim 63, the medicament injector of Cowe, Nita, and Helmer teaches the claimed invention of Claim 62, however, Cowe is silent with regards to wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Cowe, Nita, and Helmer in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage. For example, bleeding or venting air helps maintain the stability of hydraulic systems preventing issues like jerky actuator movement and inconsistent cycle times.
The medicament injector of Cowe, Nita, and Helmer modified in view of a teaching of Shill will hereinafter be referred to as the medicament injector of Cowe, Nita, Helmer, and Shill.
With regards to claim 75, the medicament injector of Cowe, Nita, and Helmer teaches the claimed invention of claim 62, however, Cowe is silent with regards to wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Cowe, Nita, and Helmer in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage. For example, bleeding or venting air helps maintain the stability of hydraulic systems preventing issues like jerky actuator movement and inconsistent cycle times.
With regards to claim 79, the medicament injector of Cowe, Nita, Helmer, and Shill teaches the claimed invention of claim 63, and Cowe further teaches wherein a vacuum is created between said end cover (44) (see [0040]) and said plurality of sealing elements (49) (see the rejection of Claim 59 where the o-ring 49 and the groove 50 are duplicated in view of a teaching of Nita) during said forward motion (see [0041], [0042], [0045] – [0049], and Figures 4 – 6).
Claim(s) 73 and 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowe and Nita as applied to claims 61 and 72 above, and further in view of Shill
With regards to claim 73, the medicament injector of Cowe and Nita teaches the claimed invention of Claim 72, however, Cowe is silent with regards to wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during a rearward motion of said medicament injection subassembly.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Cowe and Nita in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage. For example, bleeding or venting air helps maintain the stability of hydraulic systems preventing issues like jerky actuator movement and inconsistent cycle times.
With regards to claim 74, the medicament injector of Cowe and Nita teaches the claimed invention of Claim 61, however, Cowe is silent with regards to wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during a rearward motion of said medicament injection subassembly.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Cowe and Nita in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage. For example, bleeding or venting air helps maintain the stability of hydraulic systems preventing issues like jerky actuator movement and inconsistent cycle times.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim(s) 59 – 62, 64 – 67, 72 – 74, and 76 – 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 8 of U.S. Patent No. 11,786,658 B2 (hereinafter referred to as “Patent ’658”), Cowe, and Nita.
With regards to claim 59, Claim 1 Patent ’658 a medicament injector (see Col. 61, line 31) comprising:
a reusable, user-powered automatic injection assembly including a medicament injection subassembly (see Col. 61, lines 31 – 32 of Patent ’658); and
a medicament module removably insertable into said reusable, user-powered automatic injection assembly (see Col. 61, lines 33 – 34 of Patent ’658);
said medicament injection subassembly including a damping driver element, a plurality of sealing elements mounted on said damping driver element and slidable relative to a stationary surface of said reusable, user-powered automatic injection assembly, and a sealing element seating assembly which provides for varying damping of forward motion of said medicament injection subassembly along a longitudinal axis.
However, Patent ’658 is silent with regards to:
said medicament injection subassembly including a damping driver element, a plurality of sealing elements mounted on said damping driver element and slidable relative to a stationary surface of said reusable, user-powered automatic injection assembly, and a sealing element seating assembly which provides for varying damping of forward motion of said medicament injection subassembly along a longitudinal axis.
Nonetheless Cowe, which is within the analogous art of automatic injection devices with pneumatic damping (see abstract and title), teaches said medicament injection subassembly (47, 49) (see [0041]) including a damping driver element (47), a sealing element (49) mounted on said damping driver element (see [0041] “An "O" ring 49 is located around the circumference of one end of the piston 47, and is held in place by a circumferentially extended groove 50 formed around the surface of the piston.”) and slidable relative to a stationary surface (see the surface along the proximal chamber 44 in Figures 4, 5, and 6) of said reusable, user-powered automatic injection assembly and a sealing element seating assembly (50) (see [0041]) which provides for varying damping of forward motion of said medicament injection subassembly along a longitudinal axis (see [0046] – [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the medicament injection subassembly of the medicament injector of Patent ’658 in view of a teaching of Cowe such that the subassembly of the medicament injector further includes a damping driver element, an element mounted on said damping driver element and slidable relative to a stationary surface of said reusable, user-powered automatic injection assembly, and a sealing element seating assembly which provides for varying damping of forward motion of said medicament injection subassembly along a longitudinal axis. One of ordinary skill in the art would have been motivated to make this modification because Cowe teaches that this structure provides a damping mechanism of the drive element thereby reducing the risk of damage to the syringe and the device during use. See [0016], [0046], and [0050] of Cowe.
The medicament injector of Patent ’658 modified in view of Cowe will hereinafter be referred to as the medicament injector of Patent ’658 and Cowe.
However, neither Patent ’658 nor Cowe teaches the sealing element being a plurality of sealing elements.
Nonetheless Nita, which is within the analogous art of dampening structures (see [0039]), teaches that any number of absorber members such as o-rings depending on the level of vibration absorption or dampening desired (see [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the number of sealing elements of the medicament injection subassembly of the medicament injector of Patent ’658 and Cowe in view of a teaching of Nita such that the sealing element is a plurality of sealing elements mounted on the damping driver element. One of ordinary skill in the art would have been motivated to make this modification because Nita teaches that the number of sealing elements used for dampening can be adjusted to match a desired amount of dampening. See [0039] of Nita. Additionally, the number of grooves 50 of Cowe formed around the surface of the piston 47 is also modified to accommodate the number of sealing elements of the medicament injection subassembly.
The medicament injector of Patent ’658 and Cowe modified in view of a teaching of Nita will hereinafter be referred to as the medicament injector of Patent ’658, Cowe, and Nita.
With regards to claim 60, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 59, and Claim 4 of Patent ’658 further recites wherein said plurality of sealing elements and said sealing element seating assembly are configured to provide vacuum damping of said forward motion of said medicament injection subassembly along said longitudinal axis (see Col. 51, lines 51 – 55 of Patent ’658).
With regards to claim 61, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 59, and Claims 4 and 5 of Patent ’658 further recites wherein said reusable, user-powered automatic injection assembly also includes an end cover and said sealing element seating assembly with said plurality of sealing elements mounted thereon is operatively and frictionally engaged with said end cover (see Col. 61, lines 51 – 61 of Patent ’658).
With regards to claim 62, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 61, and Claim 6 of Patent ’658 further recites wherein when said sealing element seating assembly is in rearward motion, said frictional engagement with said end cover is decreased and when said sealing element seating assembly is in forward motion, said frictional engagement with said end cover is increased (see Col. 61, lines 62 – 67 of Patent ’658).
With regards to claim 64, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 61, and Claims 4, 5, and 8 of Patent ’658 further recites wherein a vacuum is created between said end cover and said plurality of sealing elements during said forward motion (see Col. 61, lines 51 – 61 and Col. 62, lines 6 – 9 of Patent ’658).
With regards to claim 65, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 59, and Claim 2 of Patent ’658 further recites wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof, said plurality of seating areas each include a planar surface and a tapered surface (see Col. 61, lines 42 – 45 of Patent ’658).
With regards to claim 66, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 65, and Claim 3 of Patent ’658 further recites wherein said plurality of sealing elements are configured to engage said planar surfaces during a rearward motion of said medicament injection subassembly and are further configured to engage said tapered surfaces during said forward motion (see Col. 61, lines 46 – 50 of Patent ’658).
With regards to claim 67, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 62, and the medicament injector of Patent ’658, Cowe, and Nita further teaches wherein said increased frictional engagement with said end cover and a vacuum created between said end cover and said plurality of sealing elements during said forward motion are configured for preventing damage to at least part of said medicament injector during said forward motion of said sealing element seating assembly (the language “wherein said increased frictional engagement with said end cover and a vacuum created between said end cover and said plurality of sealing elements during said forward motion are configured for preventing damage to at least part of said medicament injector during said forward motion of said sealing element seating assembly” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. MPEP 2114. The Office submits that the medicament injector of Patent ’658, Cowe, and Nita meets the structural limitations of the claim, and is capable of preventing damage to at least part of the medicament injector during forward motion of the sealing element seating assembly because the partial vacuum created by the O-ring and sealing element seating assembly during forward motion see Claims 1, 4, 5, and 6 of Patent ’658).
With regards to claim 72, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 60, and Claim 5 of Patent ’658 further recites wherein said reusable, user- powered automatic injection assembly also includes an end cover and said sealing element seating assembly with said plurality of sealing elements mounted thereon is operatively and frictionally engaged with said end cover (see Col. 61, lines 56 – 61 of Patent ’658).
With regards to claim 73, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 72, and Claims 5 and 7 of Patent ’658 further recites wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during a rearward motion of said medicament injection subassembly (see Col. 61, lines 56 – 61 and Col. 62, lines 1 – 5 of Patent ’658).
With regards to claim 74, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 61, and Claim 7 of Patent ’658 further recites wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during a rearward motion of said medicament injection subassembly (see Col. 62, lines 1 – 5 of Patent ’658).
With regards to claim 76, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 72, and Claim 8 of Patent ’658 further recites wherein the vacuum is created between said end cover and said plurality of sealing elements during said forward motion (see Col. 61, lines 56 – 61 and Col. 62, lines 6 – 9 of Patent ’658).
With regards to claim 77, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 61, and Claim 8 of Patent ’658 further recites wherein a vacuum is created between said end cover and said plurality of sealing elements during said forward motion (see Col. 62, lines 6 – 9 of Patent ’658).
With regards to claim 78, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 62, however, Patent ’658 is silent with regards to wherein a vacuum is created between said end cover and said plurality of sealing elements during said forward motion.
Nonetheless Cowe, which is within the analogous art of automatic injection devices with pneumatic damping (see abstract and title), teaches wherein a vacuum is created between said end cover (44) (see [0040]) and said plurality of sealing elements (49) (see the rejection of Claim 59 above where the o-ring 49 and the groove 50 are duplicated in view of a teaching of Nita) during said forward motion (see [0041], [0042], [0045] – [0049], and Figures 4 – 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the medicament injection subassembly of the medicament injector of Patent ’658, Cowe, and Nita in view of a further teaching of Cowe such that wherein a vacuum is created between said end cover and said plurality of sealing elements during said forward motion. One of ordinary skill in the art would have been motivated to make this modification because Cowe teaches that this structure provides a damping mechanism of the drive element thereby reducing the risk of damage to the syringe and the device during use. See [0016], [0046], and [0050] of Cowe.
Claim(s) 63, 75, and 79 are rejected on the ground of nonstatutory double patenting as being unpatentable over Patent ’658, Cowe, and Nita as applied to above, and further in view of Shill.
With regards to claim 63, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 62, and however, Patent ‘658 is silent with regards to further recites wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Patent ’658, Cowe, and Nita in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage. For example, bleeding or venting air helps maintain the stability of hydraulic systems preventing issues like jerky actuator movement and inconsistent cycle times.
The medicament injector of Patent ’658, Cowe, and Nita modified in view of a teaching of Shill will hereinafter be referred to as the medicament injector of Patent ’658, Cowe, Nita, and Shill.
With regards to claim 75, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 62, however, Patent ‘658 is silent with regards to wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Patent ’658, Cowe, and Nita in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage. For example, bleeding or venting air helps maintain the stability of hydraulic systems preventing issues like jerky actuator movement and inconsistent cycle times.
With regards to claim 79, the medicament injector of Patent ’658, Cowe, Nita, and Shill teaches the claimed invention of claim 63, however, Patent ’658 is silent with regards to wherein a vacuum is created between said end cover and said plurality of sealing elements during said forward motion.
Nonetheless Cowe, which is within the analogous art of automatic injection devices with pneumatic damping (see abstract and title), teaches wherein a vacuum is created between said end cover (44) (see [0040]) and said plurality of sealing elements (49) (see the rejection of Claim 59 above where the o-ring 49 and the groove 50 are duplicated in view of a teaching of Nita) during said forward motion (see [0041], [0042], [0045] – [0049], and Figures 4 – 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the medicament injection subassembly of the medicament injector of Patent ’658, Cowe, and Nita in view of a further teaching of Cowe such that wherein a vacuum is created between said end cover and said plurality of sealing elements during said forward motion. One of ordinary skill in the art would have been motivated to make this modification because Cowe teaches that this structure provides a damping mechanism of the drive element thereby reducing the risk of damage to the syringe and the device during use. See [0016], [0046], and [0050] of Cowe.
Claim(s) 80 – 82 are rejected on the ground of nonstatutory double patenting as being unpatentable over Patent ’658, Cowe, and Nita as applied to above, and further in view of Helmer.
With regards to claim 80, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 60, and, the medicament injector of Patent ‘658, Cowe, and Nita further teaches wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof (see the rejection of Claim 59 above where the sealing element seating assembly of Patent ’658 is modified to accommodate a plurality of o-rings 49 see [0041] and Figs. 4 – 6 of Cowe and [0039], [0040], Fig. 1A of Nita)
However, Patent ‘658 is silent with regards to said plurality of seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Patent ’658, Cowe, and Nita in view of a teaching of Helmer such that said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
With regards to claim 81, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 61, and, the medicament injector of Patent ‘658, Cowe, and Nita further teaches wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof (see the rejection of Claim 59 above where the sealing element seating assembly of Patent ’658 is modified to accommodate a plurality of o-rings 49 see [0041] and Figs. 4 – 6 of Cowe and [0039], [0040], Fig. 1A of Nita)
However, Patent ‘658 is silent with regards to said plurality of seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Patent ’658, Cowe, and Nita in view of a teaching of Helmer such that said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
With regards to claim 82, the medicament injector of Patent ’658, Cowe, and Nita teaches the claimed invention of claim 62, and, the medicament injector of Patent ‘658, Cowe, and Nita further teaches wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof (see the rejection of Claim 59 above where the sealing element seating assembly of Patent ’658 is modified to accommodate a plurality of o-rings 49 see [0041] and Figs. 4 – 6 of Cowe and [0039], [0040], Fig. 1A of Nita)
However, Patent ‘658 is silent with regards to said plurality of seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Patent ’658, Cowe, and Nita in view of a teaching of Helmer such that said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBERT F ALLEN/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783